Associate Director, MSAT

What you’ll do

• Lead a team of 1–2 individuals supporting phase I manufacturing of a PSC‑derived pancreatic islet cell therapy product.
• Partner with the CDMO technical team to achieve phase I manufacturing readiness and address manufacturing challenges.
• Oversee people‑in‑plant, manufacturing operator training, technical documentation, and process execution.
• Draft CMC sections for regulatory filings (IND module
  3) and other technical documents.
• Collaborate with Quality to close deviations, analyze manufacturing trends, and recommend process improvements.
• Lead investigations and troubleshoot process execution challenges using root cause analysis.
• Perform comparability studies with Research and PD teams to assess technology transfer success.
• Provide and receive feedback to support team growth and development.
• Influence multidisciplinary teams while prioritizing multiple projects and meeting deadlines.
• Drive curiosity, scientific rigor, and problem‑solving in a fast‑paced, performance‑driven environment.
• Assess talent to grow the organization and strengthen company culture.

• BSc in Chemical, Biological, or Biomedical Engineering plus 8 years (or equivalent education/work experience).
• 3+ years supporting early phase cell therapy manufacturing, including technology transfers.
• cGMP experience in regulated environments (including person‑in‑plant and/or GMP operator/supervisor).
• Experience operating perfusion bioreactors and fill/finish unit operations.
• Knowledge of PSC culture and differentiation biology to pancreatic islets.
• Experience managing a team of 2+ direct reports.
• Detail‑oriented; strong problem‑solving, technical writing, and verbal communication.
• Ability to work in multidisciplinary teams, meet deadlines, and prioritize multiple projects.
• Comfortable in a self‑driven, fast‑paced matrix environment.

Base pay range: $170,000–$210,000/year.

Travel to manufacturing site ~25% (Texas); some weekend work; lift up to 25 lbs; work in a cleanroom.

• Experience with key cell therapy equipment/unit ops for phase 1 trials (including PBS bioreactor).
• Familiarity with cell therapy drug product development (including stability studies).
• Working knowledge of DoE and RCA; grade B/ISO 7 cleanroom experience.
• Knowledge of single‑use technologies; process closure/automation.
• Analytical methods (e.g., flow cytometry) and data tools (R, Python, JMP, Flow Jo).